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Statins take on COPD: could a heart drug curb lung Flare-Ups?

NCT ID NCT04789057

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether atorvastatin, a widely used cholesterol medication, can reduce inflammation and prevent flare-ups in smokers with chronic obstructive pulmonary disease (COPD). About 460 participants will receive either atorvastatin or a placebo for several months. The goal is to see if the drug can lower the rate of COPD exacerbations and possibly reduce cancer risk, while also identifying which patients might benefit most.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 460 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject has signed Informed Consent Form and is able to understand the purpose and procedures required for the study and is willing to participate in the study. 2. Subject \[male or female\] is aged 40 years and older. 3. Subject is able to understand and comply with the protocol requirements and instructions and is likely to complete the study as planned. 4. Patients with stable COPD with persistent airflow limitation (stable COPD (post-bronchodilator FEV1\<80% of the predicted normal and post-bronchodilator FEV1/FVC\<0,70 at visit 1.) Stage II- IV) and with moderate to very severe airflow limitation according to GOLD guidelines. 5. At least two moderate/severe COPD exacerbations, or at least one leading to hospitalization or ICU admission within 12 months, preceding screening visit. 6. Current or ex-smokers who have a smoking history of at least 10 pack years. Exclusion Criteria: 1. Contraindication to statin therapy included but not limited to: known poliomyelitis, motor neuron disease, cranial or temporal arteritis, stroke or myopathy. 2. Statin use within the last 3 months prior to study start. 3. Prior diagnosis of statin induced myopathy or hypersensitivity reaction to another HMG-CoA-reductase inhibitor. 4. Using e-cigarettes or I IQOS tobacco heating system. 5. Pregnant or nursing (lactating) women. 6. Women of child bearing potential, unless they are using effective method of contraception during dosing of study treatment. 7. Patient with a clinically significant abnormality at visit 1 in investigator opinion. 8. Patients with a clinically relevant laboratory abnormality at visit 1 in investigator opinion. 9. Patients with a history of malignancy of any organ system (including lung cancer). 10. Patients unable to perform acceptable spirometry and lung volumes procedures. 11. Patients who had a COPD exacerbations that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to visit 1. 12. Patients who have had a respiratory tract infection within 4 weeks prior to visit1. 13. Patients requiring oxygen therapy (\>15hr/day) on a daily basis for chronic hypoxemia. 14. Patients with a history of asthma or onset of symptoms prior to age 40 years 15. Patients with concomitant pulmonary disease (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, tuberculosis). 16. Patients with primary bronchiectasis. 17. Patients with a diagnosis of α-1 antitrypsin deficiency (AATD). 18. Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation. 19. Active abuse of drugs or alcohol, poor compliance anticipated. 20. Use concomitant medications that are known to interact with atorvastatin: warfarin and other coumarin (vitamin K antagonists) anticoagulants, cyclosporin, gemfibrozil or other non or selective nonsteroidal anti-inflammatory drugs, proton pump inhibitors (PPIs) used by last 6 months. 21. Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study. 22. Use of other investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening visit. 23. Those unable in the opinion of the Investigator to comply fully with the study requirements.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Medical University Hospital

    Bialystok, 15-540, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.